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Dermal Laboratories Limited
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
Telephone: +44 (0)1462 458 866
Fax: +44 (0)1462 420 565
WWW: http://www.dermal.co.uk

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 02/12/2010
SPC Dermol Cream

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 02/12/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Nov-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 6.1 (List of excipients) there is a change of name from "cetomacrogol 1000" to "macrogol cetostearyl ether (cetomacrogol)"

In section 10 (date of revision of the text) the date has changed to "November 2010"
Updated on 24/03/2009 and displayed until 02/12/2010
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   01-Feb-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 9 (Renewal of the Authorisation) the date has changed to "16 February 2009"
Updated on 11/03/2009 and displayed until 24/03/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Feb-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.4 (Special warnings and precautions for use) : the following text has been added "The excipient cetostearyl alcohol may on rare occasions give rise to local skin reactions (e.g. contact dermatitis) in sensitive people."

In section 4.8 (Undesirable effects) : the following text has been added : "These reactions are very rare (<1/10,000, based on spontaneous reporting) and may be irritant or allergic in nature.  Reactions have been observed occasionally when used excessively as a leave-on application in areas of folded skin such as the anogenital area."

In section 10 (Date of revision of the text) : the date has changed to "February 2009"
Updated on 07/08/2008 and displayed until 11/03/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   01-Apr-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3 (Shelf-life): Shelf-life for 500g pack has changed to "36 months"

Section 10 (Date of revision of the text): Date has changed to "April 2008"
Updated on 21/01/2008 and displayed until 07/08/2008
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   12/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.5 - Nature and contents of container: Text deleted "High density polyethylene squeezable bottle (500g) with a polypropylene flip top cap" and text added "High density polyethylene bottle (500g) with a polypropylene metering pump"
Updated on 23/08/2004 and displayed until 21/01/2008
Reasons for adding or updating:
  • New SPC for new product